Achilles Tendon ContractureNCT03887585
Modified Percutaneous Achilles Tendon Lengthening by Triple Hemisection for Achilles Tendon Contracture
A study testing Achilles tendon lengthening in people with Achilles Tendon Contracture, run by Southwest Hospital, China at 1 site in China.
Trial summary
This study aims to evaluate the efficacy and safety of this new therapeutic method, which is based on the percutaneous sliding technique with three hemi-cuts in the tendon. Read more about this study
- Who is it for?
- Ages 3 to 80 years
- Conditions the study is for
- Achilles Tendon Contracture
- What is being tested?
- Achilles tendon lengthening
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2010to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients older than three years old;
- Severe Achilles tendon contracture and equinus;
- The time after Achilles tendon contracture more than 6 months ;
- Initial Achilles tendon lengthening.
Who cannot join
- Patients younger than 3 years;
- The course of Achilles tendon contracture is within 6 months;
- Patients who have suffered from the Achilles tendon lengthening;
- Obvious contracture of other soft tissues occurs in combination, such as compartment syndrome or extensive scar tissues in calf;
- Osteotomy or tendon transposition is needed.
- Ankle joint is damaged obviously, such as Charcot's joint or Hemophilic arthritis;
- Skin soft-tissue infection in the lower limb.
- Initial Achilles tendon lengthening.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the efficacy and safety of this new therapeutic method, which is based on the percutaneous sliding technique with three hemi-cuts in the tendon.
Read the detailed description
This study aims to provide a new therapeutic theory which bases on the percutaneous sliding technique with three hemi-cuts in the tendon. In this study, Achilles tendon parenchymal at distal level is hemisected through the most distal incision, Achilles tendon parenchymal at proximal level is hemisected through the middle incision, then Achilles tendon lengthening is accomplished by the sliding tendon under forceful dorsiflexion. It can better achieve soft tissue balance and reduce the recurrence of Achilles tendon contracture when Achilles tendon strength in plantarflexion is weakened. Thus in this study, the partial aponeurosis of gastrocnemius is cut off at most proximal incision in order to weaken Achilles tendon strength in plantarflexion.
- Conditions
- Achilles Tendon Contracture
- Being tested
- Achilles tendon lengthening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Achilles tendon lengtheningProcedure or surgery
Achilles tendon lengthening by triple hemisection for Achilles tendon contracture
| Study group | Role | What they receive |
|---|---|---|
| Achilles tendon lengthening | Experimental | Surgery of percutaneous Achilles tendon lengthening by triple hemisection Receives: Procedure: Achilles tendon lengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the American Orthopaedic Foot & Ankle Society (AOFAS) scores
The AOFAS scores of the patients before and after surgery are recorded. The scale ranges from 0-100 points, and increases of the value represent a better outcome.
Measured: Before surgery and up to 8 years after surgery
Secondary outcomes (2)
Equinus recurrence rate
The equinus recurrence rate of the patients after surgery is recorded. Lower value represents a better outcome.
Measured: Up to 8 years after surgery
Infection rate
The infection rate of the patients after surgery is recorded. Lower value represents a better outcome.
Measured: Up to 8 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start1 Jan 2010
- Primary completion30 Sep 2018
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles Tendon ContractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaojun Duan, Southwest Hospital, China
- Investigators
- Xiaojun Duan, MD, Principal investigator, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887585
- Sponsor's protocol ID
- Tendon
- Status last verified
- Mar 2019
- First submitted
- 20 Mar 2019
- Last updated
- 25 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Percutaneous Achilles Tendon Lengthening by Triple Hemisection for Achilles Tendon Contracture
- ClinicalTrials.gov ID
- NCT03887585
- Acronym / sponsor ID
- Tendon
- Conditions
- Achilles Tendon Contracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 25 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the efficacy and safety of this new therapeutic method, which is based on the percutaneous sliding technique with three hemi-cuts in the tendon.
Detailed description
This study aims to provide a new therapeutic theory which bases on the percutaneous sliding technique with three hemi-cuts in the tendon. In this study, Achilles tendon parenchymal at distal level is hemisected through the most distal incision, Achilles tendon parenchymal at proximal level is hemisected through the middle incision, then Achilles tendon lengthening is accomplished by the sliding tendon under forceful dorsiflexion. It can better achieve soft tissue balance and reduce the recurrence of Achilles tendon contracture when Achilles tendon strength in plantarflexion is weakened. Thus in this study, the partial aponeurosis of gastrocnemius is cut off at most proximal incision in order to weaken Achilles tendon strength in plantarflexion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Achilles tendon lengthening | Experimental | Procedure: Achilles tendon lengtheningSurgery of percutaneous Achilles tendon lengthening by triple hemisection |
Who may qualify
- Ages
- 3 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients older than three years old;
- Severe Achilles tendon contracture and equinus;
- The time after Achilles tendon contracture more than 6 months ;
- Initial Achilles tendon lengthening.
Key exclusion criteria (8 listed)
- Patients younger than 3 years;
- The course of Achilles tendon contracture is within 6 months;
- Patients who have suffered from the Achilles tendon lengthening;
- Obvious contracture of other soft tissues occurs in combination, such as compartment syndrome or extensive scar tissues in calf;
- Osteotomy or tendon transposition is needed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Achilles tendon lengtheningAchilles tendon lengthening by triple hemisection for Achilles tendon contracture | Procedure or surgery | Achilles tendon lengthening |
Primary outcome
Changes in the American Orthopaedic Foot & Ankle Society (AOFAS) scores
Time frame: Before surgery and up to 8 years after surgery
The AOFAS scores of the patients before and after surgery are recorded. The scale ranges from 0-100 points, and increases of the value represent a better outcome.
2 secondary outcomes
Equinus recurrence rate
Time frame: Up to 8 years after surgery
Infection rate
Time frame: Up to 8 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
Related trials for Achilles Tendon Contracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaojun Duan, MD principal investigator
Southwest Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Achilles tendon lengthening in people with Achilles Tendon Contracture, run by Southwest Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the American Orthopaedic Foot & Ankle Society (AOFAS) scores (time frame: Before surgery and up to 8 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2019.